臨床研究等提出・公開システム

A Randomized, Parallel Group, Comparative Study of the Effect of Intervention with Probiotic Products on the Vaginal Microbiota Following Vaginal Bacteriologic Examination of Artificial Insemination Patients

IUI-PIV trial

Takayama Erina

Mie University Hospital

2-174, Edobashi, Tsu city, Mie prefecture

erina-t@med.mie-u.ac.jp

Yajima Hideaki

Mie University Hospital

2-174, Edobashi, Tsu city, Mie prefecture

+81-59-232-1111

fertility-repro@clin.medic.mie-u.ac.jp

Recruiting

Dec. 11, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Participants who plan to undergo IUI treatment for any of the following conditions
abnormalities in the quantity or quality of sperm/semen, ejaculation disorders or sexual intercourse difficulties, sperm-cervical mucus incompatibility, or functional infertility.

Age of female participants
18 to 43 years old.

Participants who have provided written consent from themselves and their partners.

Individuals who have taken supplements or medications containing similar active ingredients to the investigational drug within 3 months before starting the drug.

Individuals who have taken antibiotics for 5 days or more within 3 months before starting the investigational drug.

Individuals who have participated in other clinical trials (clinical studies) within 3 months before starting the investigational drug that may have led to improvement in vaginal microbiota or other conditions.

Individuals who have experienced diarrhea, vomiting, or allergies to the therapeutic drug.

Individuals deemed unsuitable as study participants by the principal investigator or co-investigator.

Female

General infertility

Group A: Non-intervention group
Group B: Standard treatment group (antibiotics only)
Group C: New treatment group (antibiotics and probiotics III)

General infertility

Probiotics

D019936

The proportion of increase in Lactobacillus dominance to over 80% after intervention treatment in groups B and C.

The percentage of patients in Groups B and C whose Lactobacillus occupancy increased to 80% or more after the intervention, and the percentage of patients whose Lactobacillus occupancy improved after the intervention, by Lactobacillus occupancy.

Percentage of cases that improved and those that did not improve (unchanged or worsened) after treatment in Groups B and C.

Clinical pregnancy rates for the first IUI in groups B and C

First IUI clinical pregnancy rate in group A and group B patients who improved to LD

First IUI clinical pregnancy rate among group A and group C patients who improved to LD

+81-59-231-5045

Aug. 30, 2024

No

none